Claims for Patent: 10,732,111

Summary for Patent: 10,732,111

Title:	Automated immunoanalyzer system for performing diagnostic assays for allergies and autoimmune diseases
Abstract:	A quantitative method for performing an automated diagnostic assay, comprising: incubating a capture reagent with a streptavidin-coated medium to form a solid phase complex; washing the solid phase complex to remove excess capture reagent; incubating the solid phase complex with a serum sample to form an immune complex; washing the immune complex to remove any unbound sample; incubating the immune complex with a conjugate to create an immune-conjugate complex; washing the immune-conjugate complex to remove any unbound conjugate; introducing a substrate capable of generating a quantifiable response; and calibrating the response generated from introducing the substrate.
Inventor(s):	Van Cleve; Mark David (Long Beach, CA), Reid; Taylor Addison (Carlsbad, CA), Trondle; Linda Marie (Irvine, CA), Hung; Victoria (San Diego, CA), Luo; Yi (Long Beach, CA), Rieger; Dennis Edwin (Hermosa Beach, CA), McMenamy; Evan Phillip (Los Alamitos, CA), Raghavan; Nanditha (Costa Mesa, CA), Reliford; Morkoah Blay (Anaheim, CA), Canfield; Douglas John (Ludington, MI), Taine; Elaine Grace (Anaheim, CA), Sinson; Edsel Lawrence Noche (Chino Hills, CA), Vande Wetering; Scott William (Long Beach, CA), Taylor; Teri (Irvine, CA), Knox; Travis (Long Beach, CA), Cuaresma Jacalne; Fran Zylo (Anaheim, CA), Weston; James (East Lothian, GB), Bao-Guey Chan; Jennifer (San Francisco, CA), TuVi Ortega; Stephanie (Santa Ana, CA), Schell; Rachel Sarah (Torrance, CA), Diamond; Ronald Norman (Anaheim Hills, CA), Gann; Steve Michael (Huntington Beach, CA), Hall; Eric Darnell (Garden Grove, CA), Hwang; Tae Ho (Brea, CA), Morton; John Lewis (Canyon Lake, CA), Moskalev; Anatoly (Irvine, CA), Stack; Marinela Gombosev (San Clemente, CA), Sargeant; Bruce Alan (Orange, CA), Forshager; Michelle Fredrika (Vancouver, WA), Chua; Vanessa Camille (Chino Hills, CA), Wilson; Kylie (Indianapolis, IN)
Assignee:	HYCOR Biomedical, LLC (Indianapolis, IN)
Application Number:	15/482,537
Patent Claims:	1. A method for performing a diagnostic immunoassay, comprising: measuring an initial fluorescent signal associated with a quantity of streptavidin-conjugated fluorescent-labeled magnetic microparticles in a reaction cuvette for the immunoassay process, wherein the reaction cuvette contains a labeled immune-conjugate, prior to washing a labeled immune-conjugate complex in the reaction cuvette, wherein the labeled immune-conjugate complex includes a biotinylated capture reagent, the streptavidin-conjugated fluorescent-labeled magnetic microparticles, a patient antibody, and a conjugate; measuring a final fluorescent signal associated with the quantity of streptavidin-conjugated fluorescent-labeled magnetic microparticles in the reaction cuvette containing the labeled immune-conjugate complex and a chemiluminescent signal associated with the labeled immune-conjugate complex after equilibrium is reached; calculating a ratio of the final fluorescent signal to the initial fluorescent signal to obtain a bead retention ratio; and adjusting a quantifiable response for bead retention by adjusting the chemiluminescent signal by the bead retention ratio to calculate a reported value. 2. The method of claim 1, wherein the biotinylated capture reagent includes an allergen-specific human immunoglobulin E (IgE), an autoimmune-specific human immunoglobulin G (IgG), an autoimmune-specific human immunoglobulin M (IgM), or an autoimmune-specific human immunoglobulin A (IgA). 3. The method of claim 1, wherein the biotinylated capture reagent is derived from the biotinylation of a purified allergen, protein, enzyme, antibody, DNA, nuclear extract, cellular extract, or non-protein antigen. 4. The method of claim 1, wherein the biotinylated capture reagent is derived from the biotinylation of an allergen extract comprised of a multiplicity of allergens. 5. The method of claim 1, wherein the biotinylated capture reagent exists as an amalgam of multiple biotinylated capture reagents selected from purified allergens, proteins, enzymes, antibodies, and allergen extracts. 6. The method of claim 1, wherein the patient antibody is from a serum sample. 7. The method of claim 1, wherein the patient antibody is from a plasma sample. 8. The method of claim 1, further comprising incubating the biotinylated capture reagent with the quantity of streptavidin-conjugated fluorescent-labeled magnetic microparticles to form a solid phase complex. 9. The method of claim 8, wherein the step of incubating the biotinylated capture reagent with the quantity of streptavidin-conjugated fluorescent-labeled magnetic microparticles includes a reaction diluent including human serum albumin (HSA). 10. The method of claim 8, further comprising incubating an immune complex formed from the solid phase complex and a biological sample with the conjugate to form an immune-conjugate complex. 11. The method of claim 10, wherein the biological sample includes the patient antibody. 12. The method of claim 10, wherein the patient antibody binds to the biotinylated capture reagent. 13. The method of claim 10, wherein the step of incubating the immune complex with the conjugate comprises incubating with a conjugate diluent including polyethylene glycol. 14. The method of claim 1, wherein the conjugate includes a label. 15. The method of claim 14, wherein the label includes horseradish peroxidase (HRP). 16. The method of claim 1, further comprising transferring the labeled immune-conjugate complex to an optics box, wherein the final fluorescent signal and the chemiluminescent signal are quantified. 17. The method of claim 16, wherein the step of transferring the labeled immune-conjugate complex to the optics box comprises using an automated pipette arm with a reusable pipette tip. 18. The method of claim 1, further comprising: measuring fluorescence within an optics box to determine bead retention; and measuring chemiluminescence within the optics box to detect a generated relative light unit signal. 19. The method of claim 18, further comprising entering the fluorescence and chemiluminescence measurements into an algorithm to generate a bead retention adjusted relative light unit signal. 20. The method of claim 19, further comprising comparing the generated bead retention adjusted relative light unit signal to a calibration curve relative light unit signal.

Details for Patent 10,732,111

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Csl Behring Ag	CARIMUNE, CARIMUNE NF, PANGLOBULIN, SANDOGLOBULIN	immune globulin intravenous (human)	For Injection	102367	July 27, 2000		2037-04-07
Csl Behring Ag	PRIVIGEN	immune globulin intravenous (human), 10% liquid	Injection	125201	July 26, 2007		2037-04-07
Csl Behring Ag	PRIVIGEN	immune globulin intravenous (human), 10% liquid	Injection	125201	October 02, 2009		2037-04-07
Csl Behring Ag	PRIVIGEN	immune globulin intravenous (human), 10% liquid	Injection	125201	February 07, 2013		2037-04-07
Bio Products Laboratory	GAMMAPLEX	immune globulin intravenous (human)	Injection	125329	September 17, 2009		2037-04-07
Bio Products Laboratory	GAMMAPLEX	immune globulin intravenous (human)	Injection	125329	February 07, 2014		2037-04-07